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Trial registered on ANZCTR


Registration number
ACTRN12615000606583
Ethics application status
Approved
Date submitted
13/05/2015
Date registered
10/06/2015
Date last updated
6/04/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Study of SBP-101 safety and tolerability in patients with previously treated pancreatic cancer
Scientific title
A Phase 1a/1b Study of SBP-101 in Previously Treated Subjects with Locally Advanced or Metastatic Pancreatic Ductal Adenocarcinoma
Secondary ID [1] 286576 0
CL-SBP-101-01
Universal Trial Number (UTN)
Nil
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pancreatic cancer 294841 0
Condition category
Condition code
Cancer 295111 295111 0 0
Pancreatic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
SBP-101
During Phase 1a of the study, participants will be enrolled in each of 8 cohorts sequentially:
1) Cohort 1: SBP-101, 0.05 mg/kg subcutaneously, for up to 5 cycles
2) Cohort 2: SBP-101, 0.10 mg/kg subcutaneously, for up to 5 cycles
3) Cohort 3: SBP-101, 0.20 mg/kg subcutaneously, for up to 5 cycles
4) Cohort 4: SBP-101, 0.40 mg/kg subcutaneously, for up to 5 cycles
5) Cohort 5: SBP-101, 0.80 mg/kg subcutaneously, for up to 5 cycles
6) Cohort 6: SBP-101, 1.20 mg/kg subcutaneously, for up to 3 cycles
7) Cohort 7: SBP-101, 1.60 mg/kg subcutaneously, for up to 2.5 cycles
8) Cohort 8: SBP-101, 2.00 mg/kg subcutaneously, for up to 2 cycles.

All cohorts will receive subcutaneous injections of SBP-101 once daily Monday through Friday, for 3 weeks, followed by a 5- week rest period (3 weeks on, 5 weeks off = 1 cycle).


Tumour assessment will be performed at the end of each cycle 1 and every 8 weeks thereafter. If the disease is stable or a partial response is seen, participants will continue to receive cycles of SBP-101 up to the maximum number of cycles specified above until disease progression or unacceptable toxicity, whichever comes first. If a participant has a complete response prior to receiving the maximum number of allowed cycles, one additional cycle will be administered.

In Phase 1b of the study, an additional 24 participants will be enrolled at the maximum tolerated dose identified in Phase 1a to further establish the safety and tolerability of SBP-101 and to explore efficacy endpoints. Subjects in the phase 1b expansion study will receive SBP-101 subcutaneously on Monday through Friday for 3 weeks (15 doses per cycle) at the maximum tolerated dose (MTD) confirmed in Part 1a of this trial, repeated every 8 weeks (3 weeks on, 5 weeks off) for up to 5 cycles or a maximum cumulative dose of 60 mg/kg of treatment (depending on the MTD), or until disease progression or unacceptable toxicity, whichever comes first. If a participant has a complete response prior to receiving the maximum number of allowed cycles, one additional cycle will be administered.
Intervention code [1] 291695 0
Treatment: Drugs
Comparator / control treatment
No treatment
Control group
Uncontrolled

Outcomes
Primary outcome [1] 294878 0
The primary objective of the phase 1a First-Time-in-Human study is to determine the maximum tolerated dose and dose limiting toxicities (DLT) of SBP-101 in participants with previously treated locally advanced or metastatic pancreatic ductal adenocarcinoma

This will be done by monitoring each participant for study drug treatment-related toxicities at each dose level.

Timepoint [1] 294878 0
After Phase 1a completed.
Primary outcome [2] 295124 0
The primary objective of the phase 1b expansion study is to further establish the safety and tolerability of the SBP-101 at the MTD and to explore efficacy endpoints in patients with measureable disease.
This will be done by monitoring safety (number and severity of adverse events, laboratory results, vital signs, changes in bowel habits) and tumour assessment (CT/MRI scan) and tumour biomarker CA19-9.
Timepoint [2] 295124 0
After 24 subjects completed Phase 1b
Secondary outcome [1] 314268 0
To determine the adverse event profile of SBP-101.
This will be done by monitoring and recording adverse events and by monitoring clinically significant changes in safety laboratory tests, physical findings, vital signs,
electrocardiogram (ECG), and Eastern Cooperative Oncology Group (ECOG) performance status.
Timepoint [1] 314268 0
Assessed from start of treatment to end of treatment for each participant.
Secondary outcome [2] 314817 0
To describe the pharmacokinetics of SBP-101.
This will be done by collecting a number of blood and urine samples from participants.
Phase 1a- blood samples taken at Cycle 1 Day 1-2 and Day 18-19 (before study drug dose and every 30 minutes up to 4 hours, 8 hours, 10 hours and 24 hours after study drug dose) and an additional blood sample taken on Day 12 (1 hour post dose) of Cycles 1 and 2. Urine samples collected before study drug dose at Cycle 1 day 1 and a 24 hour urine collection collected at Cycle 1 day 18.
Phase 1b- blood samples taken before study drug dose at Cycle 1 day 1 and day 19 and 1 hour after dose on Cycle 1 day 19.
Timepoint [2] 314817 0
Phase 1a- blood samples taken at Cycle 1 Day 1-2 and Day 18-19 (before study drug dose and every 30 minutes up to 4 hours, 8 hours, 10 hours and 24 hours after study drug dose) and an additional blood sample taken on Day 12 (1 hour post dose) of Cycles 1 and 2. Urine samples collected before study drug dose at Cycle 1 day 1 and a 24 hour urine collection collected at Cycle 1 day 18.
Phase 1b- blood samples taken before study drug dose at Cycle 1 day 1 and day 19 and 1 hour after dose on Cycle 1 day 19.
Secondary outcome [3] 314818 0
To document any antitumor activity in subjects treated with SBP-101 .
This will be assessed by CT scan and by blood tumour marker CA19-9.
Timepoint [3] 314818 0
Assessed at baseline and then every 8 weeks (CT/MRI scan)
and 4 weeks (CA19-9) until end of treatment for each participant.

Eligibility
Key inclusion criteria
1. Histologically or cytologically confirmed locally advanced or
metastatic pancreatic ductal adenocarcinoma. Patients with acinar cell carcinoma may also be included.
2. Measurable disease on computed tomography (CT) or magnetic resonance imaging (MRI) scan by RECIST criteria (Phase 1b only)
3. ECOG Performance Status 0 or 1.
4. Received, and failed or were intolerant to at least 1 prior systemic therapy for locally advanced or metastatic pancreatic ductal adenocarcinoma
5. Adult, aged 18 years or older, male or female
6. Females of child-bearing potential must have a negative serum pregnancy test within 14 days prior to start of study treatment and must use an adequate method of contraception during the study. All sexually active males must also use an adequate method of contraception during the study
7. Adequate bone marrow, hepatic, renal and coagulation function
8. QTc interval less than or equal to 470 msec at Baseline
9. Willing and able to provide written informed consent.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Evidence of severe or uncontrolled systemic disease or any
concurrent condition that, in the opinion of the Investigator or
Medical Monitor, makes it undesirable for the subject to participate in the study or that would jeopardize compliance with the protocol. Subjects with pre-existing well-controlled diabetes are not excluded.
2. Medical or psychiatric conditions that compromise the subject's ability to give informed consent or to complete the protocol or a history of non-compliance
3. Presence of islet-cell or pancreatic neuroendocrine tumor or mixed adenocarcinoma-neuroendocrine carcinoma
4. Symptomatic central nervous system (CNS) malignancy or metastasis. Screening of asymptomatic subjects without history of CNS metastases is not required.
5. Serum albumin less than 30 g/L (3.0 g/dL)
6. Glycosylated hemoglobin (Hgb A1C) greater than 8.0%
7. Life expectancy less than 16 weeks
8. Presence of known active bacterial, fungal, or viral infection
requiring systemic therapy
9. Known infection with human immunodeficiency virus (HIV),
hepatitis B or C
10. Presence of interstitial lung disease, pulmonary fibrosis, or
pulmonary hypersensitivity reaction
11. Myocardial infarction within the last 12 months, severe/unstable angina, symptomatic congestive heart failure New York Heart Association (NYHA) class III or IV
12. Maldigestion/malabsorption syndrome pre-dating the diagnosis of pancreatic cancer
13. Known existing coagulopathy or receiving anticoagulants
14. Pregnant or lactating
15. Major surgery within 4 weeks of the start of study treatment, without complete recovery
16. Participation in any other clinical investigation within 4 weeks of receiving the first dose of study drug.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Safety
Statistical methods / analysis
Data analyses will be provided by dose groups and for all study subjects combined wherever appropriate. For continuous variables, summary statistics will include number of subjects, mean, median, standard deviation, minimum, and maximum. Categorical endpoints will be summarized using number of subjects, frequency, and percentages.
Safety analyses will be conducted for all enrolled subjects who receive at least 1 dose of study drug, whether or not they complete all protocol requirements. Safety parameters will be listed and summarized using standard descriptive statistics. Adverse event terms will be coded using the Medical Dictionary for Regulatory Activities (MedDRA) and will be summarized by dose. Incidence of adverse events occurring during the study will be summarized by system organ class (SOC) and preferred term. Adverse events will also be summarized by causality and grade. Serious adverse events will be listed separately. The rate of DLTs per dose level will be presented. All DLTs will be presented in data listings. Descriptive summary statistics will be used to summarize changes in laboratory values and vital signs by dose. Additional analyses will be performed if warranted upon review of the data.

Recruitment
Recruitment status
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
Study completed part A, sponsor decided not to proceed with part B.
Date of first participant enrolment
Anticipated
28/12/2015
Actual
4/01/2016
Date of last participant enrolment
Anticipated
31/03/2018
Actual
31/07/2017
Date of last data collection
Anticipated
Actual
5/02/2018
Sample size
Target
54
Accrual to date
Final
29
Recruitment in Australia
Recruitment state(s)
SA,VIC
Recruitment postcode(s) [1] 9545 0
5037 - Kurralta Park
Recruitment postcode(s) [2] 12365 0
3084 - Heidelberg
Recruitment outside Australia
Country [1] 7398 0
United States of America
State/province [1] 7398 0
TBC

Funding & Sponsors
Funding source category [1] 291140 0
Commercial sector/Industry
Name [1] 291140 0
Sun BioPharma Australia Pty Ltd
Country [1] 291140 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Sun BioPharma Australia Pty Ltd
Address
550 Bourke Street
Melbourne VIC 3000
Country
Australia
Secondary sponsor category [1] 289823 0
None
Name [1] 289823 0
Address [1] 289823 0
Country [1] 289823 0
Other collaborator category [1] 278438 0
Commercial sector/Industry
Name [1] 278438 0
Novotech (Australia) Pty Limited
Address [1] 278438 0
Level 3, 235 Pyrmont St
Pyrmont NSW 2009
Country [1] 278438 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292718 0
Bellberry Human Research Ethics Committee
Ethics committee address [1] 292718 0
Ethics committee country [1] 292718 0
Australia
Date submitted for ethics approval [1] 292718 0
13/05/2015
Approval date [1] 292718 0
10/09/2015
Ethics approval number [1] 292718 0
EC00372

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 56718 0
A/Prof Dusan Kotasek MB BS FRACP
Address 56718 0
Adelaide Cancer Centre,
Suite 10, Level 1, Tennyson Centre
520 South Road, Kurralta Park SA 5037
Country 56718 0
Australia
Phone 56718 0
+61 8 8292 2220
Fax 56718 0
+61 8 8292 2230
Email 56718 0
dkotasek@adelaidecancercentre.com.au
Contact person for public queries
Name 56719 0
Sheri Smith
Address 56719 0
Courante Oncology
202 Water Street, Suite 201
Excelsior, MN 55331
Country 56719 0
United States of America
Phone 56719 0
+1 952 908 9986
Fax 56719 0
Email 56719 0
ssmith@couranteoncology.com
Contact person for scientific queries
Name 56720 0
Suzanne Gagnon MD
Address 56720 0
100 Shetland Way
Collegeville, PA 19426
Country 56720 0
United States of America
Phone 56720 0
+1 215 833 3313
Fax 56720 0
Email 56720 0
sgagnon@sunbiopharma.com

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.